Process for coating a surface of a metallic stent

• US 5,891,507 A
• Filed: 07/28/1997
• Issued: 04/06/1999
• Est. Priority Date: 07/28/1997
• Status: Expired due to Term

• Current Assignee: Vascular Concepts Holdings Limited
• Original Assignee: Iowa-India Investments Company Limited
• Inventors: Jayaraman, Swaminathan
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US08/901,362
• Time in Patent Office: 617 Days
• Field of Search: 427/600, 427/601, 427/2.25, 427/2.28, 427/2.3, 427/318, 427/377
• US Class Current: 427/2.25
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: B05D 1/18 performed by dipping
• CPC Class Codes: B05D 3/12 by mechanical means
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

A metallic stent is coated with a synthetic or biological active or inactive agent that only adheres to the metallic surface of the stent and does not cover slots formed in the stent. In the method, a metallic stent is manufactured in a known manner and is then cleaned to remove surface contaminants and carbon deposits formed from cutting operations and electro-polishing procedures. The stent is then dried in a chamber in which nitrogen gas is purged and then placed in a bath containing a suitable surfactant, such as a long chain alkyl quaternary salt, that removes any residual carbon on the surface of the stent. The stent is then placed in a container filled with the coating agent and the container is placed in an ultrasonic bath. When the bath is activated, the stent swirls in the agent, which agent coats the stent but does not cover the slots of the stent. The stent is removed from the container and dried in a controlled atmosphere.

Claims

1. A process for coating a surface of a stent, the stent having a plurality of longitudinal openings therethrough, the process including the steps of:

a) immersing said stent within a coating agent in a container;

b) placing the container in an ultrasonic bath and subjecting said stent and coating agent within the container to ultrasonic energy;

c) said stent swirling within said coating agent when subjected to ultrasonic energy, said stent being coated with said coating agent with said longitudinal openings left uncoated.

2. The process of claim 1, wherein said coating agent is selected from the group consisting of heparin, EDGF and VGFs.

3. The process of claim 1, wherein said coating agent is selected from the group consisting of silicone, polyurethane and polytetrafluoroethylene.

4. The process of claim 1, further including the step, prior to said immersing step, of placing said stent in a bath of deionized water and boiling said water for twenty minutes to forty-five minutes.

5. The process of claim 4, wherein, after said placing and boiling steps, including the step of drying said stent in a nitrogen-purged atmosphere for eight to twelve hours.

6. The process of claim 5, further including the step, after said drying step, of bathing said stent in a surfactant.

7. The process of claim 6, wherein said surfactant comprises a long chain alkyl quaternary salt of at least 12 C atoms.

8. The process of claim 1, prior to said immersing step, including the step of electro-polishing said stent.

9. A process for coating a surface of a stent, the stent having a plurality of openings therethrough, the process including the steps of:

a) electro-polishing said stent;

b) placing said stent in a bath of deionized water and boiling said water for twenty minutes to forty-five minutes;

c) drying said stent in a nitrogen-purged atmosphere for eight to twelve hours;

d) bathing said stent in a surfactant comprising a long chain alkyl quaternary salt of at least 12 C atoms;

e) immersing said stent within a coating agent selected from the group consisting of heparin, EDGF, VGFs, silicone, polyurethane and polytetrafluoroethylene;

f) subjecting said stent and coating agent to ultrasonic energy, said stent swirling within said coating agent and being coated with said coating agent with said openings left uncoated; and

g) drying said stent in a controlled atmosphere.